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| Name | Class |
|---|---|
| Yorkshire Cancer Research | OTHER |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
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This study will monitor the effect on patients reported outcomes (PROMs) of VATS resection and SABR for NSCLC delivered at the Leeds Cancer Centre The investigator will support with this information the Shared Decision Making (SDM) process.
300 consecutive patients will be followed up from prior the treatment to 12 months afterwards, administering multiple questionnaires (EORTC QLQ C-30 and LC-13, PSQ-18, Decision Self-Efficacy Scale) by a remote web-based system.
Deliverable:
Methods
Aim and Objectives
This study aims to describe the trajectory of lung cancer patients HRQoL, symptoms and functions following VATS or SABR treatment for Stage I-II NSCLC and to determine the feasibility and patient acceptability of online self-reporting of PROMs.
Specific objectives of the study include:
Design
This is an observational prospective longitudinal study with repeated measures (PROMs), employing a convenience sample of consecutive patients planned to have VATS resections or SABR for stages I-II of NSCLC. Outcomes measures will be collected prior to treatment and 1,3,6,12 months afterwards, administering the questionnaires by the remote web-based system. Paper administration will be offered to patients without Internet access.
Sample size considerations
Last year 100 pre-surgical quality of life questionnaires have been collected in 5 months from outpatients' clinic at Leeds Cancer Centre (LCC). For longitudinal studies involving regular PROMs, the investigators typically see 70% consent rate and 30-35% attrition over 3 months24. Therefore the investigators expectations are to be able to recruit 200 VATS and 50 SABR patients recruiting over 12 months with 12 months of follow-up.
In order to detect a minimum difference of 10% from the baseline value and standard deviation of the EORTC QLQ-C30 Global Health Scale scale (as measured in our historical cohort of 115 anatomic lung resections), with a alfa level of 0.05 and statistical power of 90%, a sample size of 115 patients in the surgical arm was estimated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Patients | Early stage NSCLC patients submitted to Surgical Resection |
| |
| SABR Patients | Early stage NSCLC patients submitted to SABR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EORTC QLQ-C30 (version 3.0). | Other | Quality of Life Questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Reported Outcomes | Quality of life (EORTC QLQ-C30 and LC13 questionnaire) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decision self-efficacy scale | Patient perspectives of the Shared Decision Making Process. | 3 months |
| Patient Acceptability | Patient acceptability explored through interviews |
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Inclusion Criteria:
Exclusion Criteria:
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Early stage Non-Small Cell Lung Cancer patients
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28932579 | Derived | Pompili C, Franks KN, Brunelli A, Hussain YS, Holch P, Callister ME, Robson JM, Papagiannopoulos K, Velikova G. Patient reported outcomes following video assisted thoracoscopic (VATS) resection or stereotactic ablative body radiotherapy (SABR) for treatment of non-small cell lung cancer: protocol for an observational pilot study (LiLAC). J Thorac Dis. 2017 Aug;9(8):2703-2713. doi: 10.21037/jtd.2017.07.35. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| PS Q18 | Other | Patients Satisfaction Questionnaire |
|
| Decision Self-Efficacy Scale | Other | Questionnaire |
|
| 12 months |
| Clinician Acceptability | clinician acceptability explored through interviews | 12 months |
| Patients satisfaction | patients satisfaction of the care received (PSQ-18 Patient satisfaction questionnaire) | 1 month |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |